Expanded Use of De Novo Pathway Offers Opportunity
for Device Manufacturers

By Amy Scanlin, EAS Consulting Group, LLC

When applicable, the process provides novel products with a speedier route to market.

Three Areas Where Tissue Engineering Is Changing Medical Treatment

By Nathan Müller, Starfish Medical

Tissue scaffolding, nerve grafting and skin printing hold promise, but there is much more work to be done.

Devine Guidance

Problematic DHRs, Oh My!

By Dr. Christopher Joseph Devine,
Devine Guidance International

Can your company prove its device has been manufactured in accordance with its DMR?

Featured Quote

We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.

— Scott Gottlieb, M.D., FDA

In Vitro Diagnostics Registration and Reimbursement in China

By Ames Gross, Pacific Bridge Medical

Access to the IVD market in China is lengthy and complicated.

IVDR signals In Vitro Industry Shake-up

By Brian Moan and Norman Rabin, Maetrics

Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.

HSCA Releases Extensive Cybersecurity Considerations

By MedTech Intelligence Staff

The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.